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In the last decade the concept of geriatric evaluation and management (GEM) has been widely discussed in the literature. Studies of GEM have occurred primarily in three settings: inpatient units, outpatient clinics, and specialized types of home care. We have reviewed the literature, focusing on randomized trials, to determine the strength of the evidence for the efficacy of these interventions. Two single-site randomized controlled trials of inpatient GEM units have been conducted and indicate that such units that provide care to targeted disabled older patients probably have a favorable impact on subsequent physical function, rates of institutionalization, and mortality. Two randomized trials of inpatient GEM consultation teams have been conducted. The trial that did not target high-risk individuals showed no benefit while the trial that did target an at-risk group showed that those receiving the service had improvements in mental status and short-term mortality. The results of randomized trials of outpatient GEM clinics to date have been unimpressive. Two trials of in-home GEM by a trained observer tended to show that the service resulted in a reduction in mortality. To date randomized trials of GEM have been very heterogeneous in terms of the type of assessment and subsequent care, the site in which services are delivered, and the manner in which patients are selected for the studies. This limits the ability to compare and extrapolate across studies. In the future there is a need to better clarify the selection of study participants, the exact structure of the assessment intervention provided, and the elements of successful interventions that may be most critical to insuring a good outcome.
Comprehensive geriatric assessment is a technique for multidimensional diagnosis of frail elderly people with the purpose of planning and/or delivering medical, psychosocial, and rehabilitative care. When comprehensive geriatric assessment is coupled with some therapy, then the term geriatric evaluation and management (GEM) will be used. Following a brief history of comprehensive geriatric assessment, we describe the varied patterns of GEM program organization and review the literature of studies examining GEM effectiveness. Program diversity complicates drawing firm conclusions about GEM effects; however, the vast majority of studies report positive, if not uniformly significant, results. Our analysis suggests that much of the variability in findings is due to sample size limitations. In order to reach conclusions of program effects across studies and to avoid problems of small sample sizes, we undertook a formal meta-analysis. In this initial meta-analysis, we sought to evaluate the effect of GEM programs on a single outcome: mortality. We pooled all published GEM controlled trials into four major groups: inpatient consultation services, inpatient GEM units, home assessment services, and outpatient GEM programs. Meta-analysis of 6-month mortality demonstrates a 39% reduction of mortality for inpatient consultation services (odds ratio 0.61, 95% confidence interval 0.46-0.81, P = 0.0008) and a 37% reduction of mortality for inpatient GEM units (odds ratio 0.63, 95% CI 0.42-0.93, P = 0.02). Home assessment services reduced mortality by 29% (odds ratio 0.71, 95% CI 0.55-0.90, P = 0.005). On the other hand, no significant survival effect was found for outpatient GEM programs (odds ratio 0.96, 95% confidence interval 0.61-1.49).(ABSTRACT TRUNCATED AT 250 WORDS)
A multi-site randomized controlled trial could most conclusively establish the efficacy of geriatric evaluation and management units, but many questions must be answered to design such a trial. First, the research questions needs to be rigorously specified. This will facilitate decisions concerning the types of patients to be included in the study. Second, the intervention requires a clear definition, including its component parts, to improve replication across multiple sites. Third, the type of randomization (ie, by hospital or by patient) and the timing of randomization (ie, at admission or at some later point during care) need to be considered. Fourth, because this type of intervention cannot be administered in a blind fashion, bias is a critical concern. Outcome measures must be selected carefully so that those least susceptible to bias are given the highest priority. Despite the need to address all of these questions, the time is upon us to conduct a multi-site trial of geriatric evaluation and management programs.
Researchers generally agree that Geriatric Evaluation and Management (GEM) Units are effective only when they are targeted at a specific group of frail, elderly patients who are most likely to benefit. Such patients are those who are neither too sick (eg, severely demented or moribund) nor too well. Various strategies for identifying such patients have been employed by investigators with little consensus on the most efficient targeting criteria. Criteria most often use for inclusion in GEM programs are various combinations of patient age, degree of functional impairment, presence of geriatric conditions (eg falls, incontinence, confusion), particular diagnostic conditions (eg, multiple disorders), and psychosocial conditions (eg, living alone, recent bereavement, low income). Commonly used exclusion factors are severe dementia, inevitable nursing home placement, and terminal illness. Outcome studies suggest that beneficial effects of GEM care are most apparent when patients are selected using specific clinical criteria. Future research on targeting should address the potential need for differing criteria in different settings (eg, inpatient vs outpatient GEM units), simplifications of criteria for greatest ease of application, and prospective evaluation of which criteria best predict functional improvement, longer survival, and reduced health care expenditures in response to GEM care.
To maximize the cost effectiveness of geriatric evaluation and management (GEM) programs, criteria need to be established for selecting patients most likely to benefit. A working group was convened to define appropriate patient selection (targeting) criteria for each type of GEM program and to consider research questions for future targeting studies. The group outlined targeting criteria for the spectrum of GEM program types and locations. GEM program types included: inpatient GEM units; hospital geriatric consultation service; GEM programs in nursing homes; outpatient GEM programs for functionally impaired persons; and geriatric community outreach/screening programs for functionally independent elders. For each program type, the group outlined targeting criteria based on current literature and experience. Because research has not yet established the effectiveness of many of these patient targeting strategies, the group drafted a set of research questions, pertinent to targeting, that require attention: (1) For each identifiable population of elderly people, who are most likely to benefit from GEM? (2) How should these people best be identified/targeted? (3) What criteria should be used for targeting? (4) How and how often should population screening be performed to identify persons in need of GEM?
Methods of conducting comprehensive geriatric evaluation and management (GEM) are proliferating in a variety of clinical settings. However, rigorous evaluations of efficacy for this new approach to care of older patients have demonstrated a favorable impact on patient outcome in only a few studies. All of these have been controlled single site studies, and replication is needed. If replication studies show similar results, further studies should be undertaken to define the minimum necessary intervention to achieve the desired outcome. Controlled trials are needed to determine if consultative geriatric evaluation and/or primary patient management is effective. Further innovative work is needed in model development for geriatric assessment and management in outpatient settings. Finally, studies of geriatric evaluation and management in other environments, such as home care or the nursing home, are recommended.
Methodological issues relating to multi-site studies of inpatient geriatric evaluation and management units were the focus of this working group's deliberations. The group favored a randomized clinical trial in which the inpatient geriatric evaluation and management unit was coupled with outpatient geriatric care. Inclusion of a broad spectrum of patients stratified according to risk for poor hospital outcomes was proposed in order to obtain information on the types of patients that would be most likely to benefit. The need for a detailed definition and description of care in the unit and of "usual care" was emphasized. Serious concerns were raised about including both VA medical centers and private hospitals in the same trial due to differences in the implementation of such a program. Furthermore, fears of contamination of the control group suggested that hospitals could be randomized either to provide usual care or have a GEM unit. However, this strategy would necessitate that hospitals that have already developed inpatient GEM units would be excluded from the trial and could be costly because of the number of hospitals that would be required.
Issues related to measuring outcomes of care in geriatric evaluation and management (GEM) units were identified by the outcomes working group of the GEM evaluation conference. GEM units have as a major goal the improvement or maintenance of both physical and psychosocial function. Suggested outcome measures for physical health included survival, restricted activity days, general health perceptions, comprehensive physical function, and miscellaneous specific types of functioning. In the area of psycho-social function, the working group suggested measuring cognitive function, affect/life satisfaction, social function, and satisfaction with care. The patient's caregiver (eg, spouse or child) is often an important target of GEM care, and the group suggested measuring caregiver burden, life satisfaction, and assessment of patient behavior problems. While the primary goal of GEM units is to improve health status, their effects on the utilization and cost of health care are important to decisions about wide-spread implementation and funding. The group therefore suggested a comprehensive assessment of these outcomes. Among the large array of recommended outcomes, the most important were thought to be mortality, function, and cost.
In this paper, we present the consensus statement from a national conference on research priorities and methodologies for studying geriatric evaluation and management (GEM) programs. These conclusions, discussion points, and recommendations resulted from discussions of plenary papers, working group deliberations, and a final session in which findings were synthesized by the conference co-chairmen and presented to conference participants for final review. Major conclusions included: (1) The importance of linking geriatric evaluation with care management in future studies; (2) The need for multi-center trials of inpatient units to establish efficacy; (3) The importance of studying criteria for targeting GEM care on patients who are most likely to benefit; (4) The need for further developmental studies of outpatient GEM clinics; (5) The importance of assessing a range of outcomes including mortality, patient function, satisfaction, caregiver burden, and cost; and (6) The need to define more carefully the nature of the intervention that is being studied to aid in comparing and extrapolating findings. The following research priorities for GEMS were formulated based on the conference: (1) Within the VA health care system, a multi-site randomized trial of inpatient GEM units should be initiated; (2) Multi-site studies of inpatient GEM units and consultation teams linked to outpatient care should be initiated in non-VA settings; (3) Studies should identify the components of GEM that are most critical to outcome; (4) Studies should explore efficacy of GEM in settings that have not been well studied to date such as nursing homes; and (5) Studies are needed to test screening methods and targeting criteria for GEM in all settings.
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Evolving definitions of frailty, and improved understanding of molecular and physiological declines in multiple systems that may increase vulnerability in frail, older adults has encouraged investigators from many disciplines to contribute to this emerging field of research. This article reports on the results of the 2004 American Geriatrics Society/National Institute on Aging conference on a Research Agenda on Frailty in Older Adults, which brought together a diverse group of clinical and basic scientists to encourage further investigation in this area. This conference was primarily focused on physical and physiological aspects of frailty. Although social and psychological aspects of frailty are critically important and merit future research, these topics were largely beyond the scope of this meeting. Included in this article are sections on the evolving conceptualization and definitions of frailty; physiological underpinnings of frailty, including the potential contributions of inflammatory, endocrine, skeletal muscle, and neurologic system changes; potential molecular and genetic contributors; proposed animal models; and integrative, system biology approaches that may help to facilitate future frailty research. In addition, several specific recommendations as to future directions were developed from suggestions put forth by participants, including recommendations on definition and phenotype development, methodological development to perform clinical studies of individual-system and multiple-system vulnerability to stressors, development of animal and cellular models, application of population-based studies to frailty research, and the development of large collaborative networks in which populations and resources can be shared. This meeting and subsequent article were not meant to be a comprehensive review of frailty research; instead, they were and are meant to provide a more-targeted research agenda-setting process.
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Despite continued improvement in incidence of acute immune injury and short-term graft survival, late allograft dysfunction remains a significant problem in the renal transplant population. Recent reports suggest that rates of renal function decline are quite varied in the overall recipient population, and that individual rates for many recipients may not change substantially over time. Moreover, analyses also reveal distinct predictive factors for both early and late functional decline. Long-term outcome studies for renal transplantation, however, might be significantly limited by incomplete data sets for assessing clinical endpoints. In view of the heterogeneous factors that may cause progressive allograft injury, more routine biopsy sampling would allow a more complete characterization of induced injuries. Elucidating mechanisms of renal fibrosis in response to injury, in experimental systems and humans, is also an important goal in better understanding chronic allograft damage. Regulation of cell senescence genes and epithelial to mesenchymal transition, studied in other models of renal fibrosis, are likely relevant to studies of renal allograft dysfunction. Recent technical advances in analyzing biological samples may play a pivotal role in identifying and validating surrogate markers of allograft function for future interventional trials in transplantation.
Several decades have lapsed since the original description of retroviral infection of the central nervous system (CNS) appeared. With the recent arrival of the autoimmune deficiency syndrome (AIDS) epidemic and the associated human retroviral encephalitis, interest in murine models has been rekindled. In most of the published studies, susceptible mouse strains are infected as neonates with molecularly cloned type-C retroviruses. In most models, a spongiform encephalopathy follows an early CNS endothelial cell infection. The subsequent pathogenesis of this encephalopathy is unknown. In some models neuronal and glial infection is seen, while in others only non-neuroglial elements are infected. This variation can be traced to differences in strains of mice and viruses in addition to differences in assays. The different models offer fertile experimental ground to decipher the role of direct versus indirect neuroglial damage. Reconciliation of these various models where the final neuropathology appears so similar, may be the key to understanding their pathogenesis.